HIVPhase 4DRIVESHAFTNCT01423812
DRIVESHAFT: Darunavir/Ritonavir In HIV-infected Virologically-suppressed Experienced Subjects
A Phase 4 study testing Twice-daily combination Darunavir and ritonavir and Once-daily combination Darunavir and ritonavir in people with HIV, run by Ruth M. Rothstein CORE Center at 1 site in United States.
Trial summary
Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that evolved from a prototype compound synthesized using structure-based design strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Twice-daily combination Darunavir and ritonavir and Once-daily combination Darunavir and ritonavir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ART-experienced, HIV-1 infected subjects ≥18 years of age.
- A female subject is eligible to enter and participate in the study if she:
- is of non-childbearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy, or bilateral oophorectomy or,
- is of child-bearing potential, with a negative pregnancy test at both Screen and Day 1 and agrees to one of the following methods of contraception to avoid pregnancy:
- Complete abstinence from intercourse from 2 weeks prior to administration of study medications, throughout the study, and for at least 2 weeks after discontinuation of all study medications.
- Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
Show all 14Show fewer
- Approved hormonal contraception may be administered with darunavir/ritonavir
- Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
- Any other method with published data showing that the expected failure rate is <1% per year.
- Any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
- CD4 >50 cells/mm3
- HIV-1 RNA concentrations at undetectable levels (according to local assay being used) for at least 12 weeks on stable current regimen
- Current regimen includes darunavir/ritonavir 600/100 mg twice-daily plus a minimum of two other antiretrovirals
- Negative serum pregnancy test at screening visit
Who cannot join
- Subjects meeting any of the following criteria must not be enrolled in the study:
- Known hypersensitivity reaction to agents being utilized in the study
- >1 cumulative darunavir associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V, or L89V) detected from any previous genotype or a VircoTYPE HIV-1 darunavir fold-change >10.0 on any previous virtual phenotype
- Pregnant or breast feeding woman
- Liver dysfunction with Child-Pugh class C disease or decompensated cirrhosis
Trial locations and contacts
1 site in 1 country.
United States1 site
Ruth M. Rothstein CORE Center
Chicago, Illinois, 60612
About this study
Official title: DRIVESHAFT: Phase IV Randomized, Open-Label Study in HIV-1 Virologically-suppressed Patients On Regimens With Darunavir 600mg/Ritonavir 100mg Twice-daily Switching to Darunavir 800mg/Ritonavir 100mg Once-daily Vs. Continuing Twice-daily Darunavir/Ritonavir Regimens
Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that evolved from a prototype compound synthesized using structure-based design strategies. Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced patients, darunavir was initially approved for twice-daily administration boosted with twice-daily ritonavir at 600mg and 100mg, respectively. Recently, once-daily darunavir/ritonavir was approved for use in treatment-experienced adult patients with viremia with no darunavir resistance mutations. In treatment-experienced patients with viral suppression, switching from an antiretroviral taken twice-daily to a once-daily dose is an attractive option to promote greater patient acceptability and adherence, and potentially minimize side effects and toxicities. Because of darunavir/ritonavir's high genetic barrier to resistance and well-established safety profile at a once-daily dose, switching patients with virologic suppression from twice-daily darunavir/ritonavir to once-daily darunavir/ritonavir will likely confer attributes more favorable to patients through a simplified dosing schedule and lower potential for lipid elevation without the loss of virologic control. DRIVESHAFT is a 48-week Phase 4, randomized, open label, comparative study. The study will be conducted in 60 HIV-1 infected, antiretroviral experienced, virologically-suppressed patients on regimens containing darunavir 600mg/ ritonavir 100mg twice-daily and a minimum of two other antiretrovirals, with a history of 0-1 darunavir-associated resistance mutations. Subjects will be randomized 1:1 to switch to darunavir 800mg/ ritonavir 100mg once-daily or continue on their current regimen. Rates of virologic suppression of once-daily darunavir/ritonavir regimens relative to darunavir/ritonavir twice-daily regimens will be compared, and safety, change from baseline fasting lipid parameters, and adherence will be evaluated.
Read the detailed description
The Darunavir/Ritonavir In Virologically-suppressed Experienced Subjects Halving an Antiretroviral by Finetuning Therapy (DRIVESHAFT) study was a prospective, randomized, single-centre, two-arm, open-label 48-week pilot study. The aim of DRIVESHAFT was to evaluate the safety and efficacy of switching the DRV/r component from twice-daily to once-daily 800/100 mg compared with those remaining on current therapy among HIV-1-infected, treatment-experienced patients with 0-1 DRV RAMs on a stable regimen including twice-daily DRV/r 600/100 mg. The study was conducted at The Ruth M Rothstein CORE Center (Chicago, IL, USA). The sample size was determined upon feasibility as a single-site study and not powered for non-inferiority. Study enrolment was planned for 60 participants randomized 1:1 to one of two arms: the switch arm from DRV/r 600/100 mg twice daily to DRV/r 800/100 mg once/daily plus current ARV regimen including a minimum of two other agents or remain on current ARV regimen with minimum of three agents inclusive of twice-daily DRV/r. Two DRV 400 mg tablets were used in the once-daily DRV/r arm, with DRV 600 mg tablets administered in the twice-daily DRV/r arm.
DRIVESHAFT inclusion criteria included HIV-1-infected adult (>18 years of age), HIV-1 RNA measurements <40 copies/ml (using a local assay) over at least 12 weeks on a stable regimen including DRV/r 600/100 mg twice daily plus a minimum of two other ARVs, screening HIV-1 RNA<40 copies/ml, have undergone genotypic testing at any time prior to starting current antiretroviral therapy (ART) with evidence of <2 cumulative DRV RAMs, CD4+ T-cell count >50 cells/mm3, and a negative serum pregnancy test at screening visit Participants who were randomized and received at least one dose of study medication were included in efficacy analysis, and the primary end point was the proportion of participants with HIV-1 RNA<40 copies/ml at week 48.
- Conditions
- HIV
- Being tested
- Twice-daily combination Darunavir and ritonavir, Once-daily combination Darunavir and ritonavir
- Keywords
- HIV, treatment-experienced, protease inhibitor, adherence, lipids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Twice-daily combination Darunavir and ritonavirDrug
Also called Prezista and norvir twice-daily
Subjects randomized 1:1 to remain on regimens containing combination Darunavir 600mg plus Ritonavir 100mg twice-daily
Once-daily combination Darunavir and ritonavirDrug
Also called Prezista and norvir once-daily
Subjects randomized 1:1 to switch to from combination Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to the experimental combination Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Once-daily Darunavir and ritonavir | Experimental | Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily Receives: Drug: Once-daily combination Darunavir and ritonavir |
| Twice-daily Darunavir and ritonavir | Active comparator | Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily Receives: Drug: Twice-daily combination Darunavir and ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects
Proportion of subjects with plasma HIV-1 RNA <40 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's "snapshot" algorithm
Measured: 48 weeks after randomization to study medication
Secondary outcomes (6)
Secondary Efficacy Endpoints
•Proportion of subjects with plasma HIV-1 RNA >200 c/mL at Week 24
Measured: Within 24 weeks after randomization to study medication
Change in Total Cholesterol From Baseline to 48 Weeks
Absolute change in lipid parameter (total cholesterol mg/dl) of once-daily versus twice-daily darunavir/ritonavir containing regimens over 48 weeks
Measured: Within 48 weeks of randomization baseline to study medications
Absolute Value Change in CD4+ From Baseline to Week 48
Absolute value increase in CD4+ cells/mm3 from baseline to week 48
Measured: 48 weeks after randomization baseline to study medications
Assessment of Virologic Failure
•Assess the development of viral resistance in subjects experiencing virological failure
Measured: Within 48 weeks of randomization to study medications
Number of Participants With Greater Than 95% Adherence at 48 Weeks
Characterize adherence to once-daily versus twice-daily darunavir/ritonavir containing regimens using the Modified Medication Adherence Self-Report Inventory (M-MASRI) scale
Measured: Within 48 weeks of randomization to study medications
Secondary Efficacy Endpoints
•Proportion of subjects with plasma HIV-1 RNA <40 c/mL at Week 24
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth M. Rothstein CORE Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Responsible party
- Principal investigator, Gregory Huhn, Ruth M. Rothstein CORE Center
- Investigators
- GREGORY G HUHN, MD, Principal investigator, The Ruth M. Rothstein CORE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423812
- Sponsor's protocol ID
- TMC114HIV4063
- Acronym
- DRIVESHAFT
- Status last verified
- Jun 2023
- First submitted
- 24 Aug 2011
- Last updated
- 19 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.
PubMed 20386077Huhn GD, Sigman A, Livak B. Simplification from twice-daily to once-daily darunavir/ritonavir in a randomized trial among HIV-infected persons with HIV-1 RNA suppression on antiretroviral therapy. Antivir Ther. 2015;20(8):849-54. doi: 10.3851/IMP2962. Epub 2015 Apr 17.
PubMed 25881614
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRIVESHAFT: Phase IV Randomized, Open-Label Study in HIV-1 Virologically-suppressed Patients On Regimens With Darunavir 600mg/Ritonavir 100mg Twice-daily Switching to Darunavir 800mg/Ritonavir 100mg Once-daily Vs. Continuing Twice-daily Darunavir/Ritonavir Regimens
- ClinicalTrials.gov ID
- NCT01423812
- Acronym / sponsor ID
- DRIVESHAFT / TMC114HIV4063
- Conditions
- HIV
- Keywords
- HIV, treatment-experienced, protease inhibitor, adherence, lipids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ruth M. Rothstein CORE CenterUniversity, hospital or other
- Collaborators
- Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 7 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Darunavir is a nonpeptidic protease inhibitor with a high genetic barrier to resistance that evolved from a prototype compound synthesized using structure-based design strategies. Once-daily darunavir at 800mg boosted with 100mg of ritonavir is an effective antiretroviral agent indicated for HIV-infected treatment-naïve patients. In treatment-experienced patients, darunavir was initially approved for twice-daily administration boosted with twice-daily ritonavir at 600mg and 100mg, respectively. Recently, once-daily darunavir/ritonavir was approved for use in treatment-experienced adult patients with viremia with no darunavir resistance mutations. In treatment-experienced patients with viral suppression, switching from an antiretroviral taken twice-daily to a once-daily dose is an attractive option to promote greater patient acceptability and adherence, and potentially minimize side effects and toxicities. Because of darunavir/ritonavir's high genetic barrier to resistance and well-established safety profile at a once-daily dose, switching patients with virologic suppression from twice-daily darunavir/ritonavir to once-daily darunavir/ritonavir will likely confer attributes more favorable to patients through a simplified dosing schedule and lower potential for lipid elevation without the loss of virologic control. DRIVESHAFT is a 48-week Phase 4, randomized, open label, comparative study. The study will be conducted in 60 HIV-1 infected, antiretroviral experienced, virologically-suppressed patients on regimens containing darunavir 600mg/ ritonavir 100mg twice-daily and a minimum of two other antiretrovirals, with a history of 0-1 darunavir-associated resistance mutations. Subjects will be randomized 1:1 to switch to darunavir 800mg/ ritonavir 100mg once-daily or continue on their current regimen. Rates of virologic suppression of once-daily darunavir/ritonavir regimens relative to darunavir/ritonavir twice-daily regimens will be compared, and safety, change from baseline fasting lipid parameters, and adherence will be evaluated.
Detailed description
The Darunavir/Ritonavir In Virologically-suppressed Experienced Subjects Halving an Antiretroviral by Finetuning Therapy (DRIVESHAFT) study was a prospective, randomized, single-centre, two-arm, open-label 48-week pilot study. The aim of DRIVESHAFT was to evaluate the safety and efficacy of switching the DRV/r component from twice-daily to once-daily 800/100 mg compared with those remaining on current therapy among HIV-1-infected, treatment-experienced patients with 0-1 DRV RAMs on a stable regimen including twice-daily DRV/r 600/100 mg. The study was conducted at The Ruth M Rothstein CORE Center (Chicago, IL, USA). The sample size was determined upon feasibility as a single-site study and not powered for non-inferiority. Study enrolment was planned for 60 participants randomized 1:1 to one of two arms: the switch arm from DRV/r 600/100 mg twice daily to DRV/r 800/100 mg once/daily plus current ARV regimen including a minimum of two other agents or remain on current ARV regimen with minimum of three agents inclusive of twice-daily DRV/r. Two DRV 400 mg tablets were used in the once-daily DRV/r arm, with DRV 600 mg tablets administered in the twice-daily DRV/r arm.
DRIVESHAFT inclusion criteria included HIV-1-infected adult (>18 years of age), HIV-1 RNA measurements <40 copies/ml (using a local assay) over at least 12 weeks on a stable regimen including DRV/r 600/100 mg twice daily plus a minimum of two other ARVs, screening HIV-1 RNA<40 copies/ml, have undergone genotypic testing at any time prior to starting current antiretroviral therapy (ART) with evidence of <2 cumulative DRV RAMs, CD4+ T-cell count >50 cells/mm3, and a negative serum pregnancy test at screening visit Participants who were randomized and received at least one dose of study medication were included in efficacy analysis, and the primary end point was the proportion of participants with HIV-1 RNA<40 copies/ml at week 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once-daily Darunavir and ritonavir | Experimental | Drug: Once-daily combination Darunavir and ritonavirSubjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily to Darunavir 800mg plus Ritonavir 100mg once-daily |
| Twice-daily Darunavir and ritonavir | Active comparator | Drug: Twice-daily combination Darunavir and ritonavirSubjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- ART-experienced, HIV-1 infected subjects ≥18 years of age.
- A female subject is eligible to enter and participate in the study if she:
- Any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study should be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide).
- CD4 >50 cells/mm3
- HIV-1 RNA concentrations at undetectable levels (according to local assay being used) for at least 12 weeks on stable current regimen
Key exclusion criteria (5 listed)
- Known hypersensitivity reaction to agents being utilized in the study
- >1 cumulative darunavir associated mutations (V11I, V32I, L33F, I47V, I50V, I54L or M, T74P, L76V, I84V, or L89V) detected from any previous genotype or a VircoTYPE HIV-1 darunavir fold-change >10.0 on any previous virtual phenotype
- Pregnant or breast feeding woman
- Liver dysfunction with Child-Pugh class C disease or decompensated cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Twice-daily combination Darunavir and ritonavirAlso: Prezista and norvir twice-dailySubjects randomized 1:1 to remain on regimens containing combination Darunavir 600mg plus Ritonavir 100mg twice-daily | Drug | Twice-daily Darunavir and ritonavir |
| Once-daily combination Darunavir and ritonavirAlso: Prezista and norvir once-dailySubjects randomized 1:1 to switch to from combination Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to the experimental combination Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks | Drug | Once-daily Darunavir and ritonavir |
Primary outcome
Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects
Time frame: 48 weeks after randomization to study medication
Proportion of subjects with plasma HIV-1 RNA <40 c/mL at Week 48 using a Missing, Switch, or Discontinuation = Failure (MSDF) algorithm as codified by the FDA's "snapshot" algorithm
6 secondary outcomes
Secondary Efficacy Endpoints
Time frame: Within 24 weeks after randomization to study medication
Change in Total Cholesterol From Baseline to 48 Weeks
Time frame: Within 48 weeks of randomization baseline to study medications
Absolute Value Change in CD4+ From Baseline to Week 48
Time frame: 48 weeks after randomization baseline to study medications
Assessment of Virologic Failure
Time frame: Within 48 weeks of randomization to study medications
Number of Participants With Greater Than 95% Adherence at 48 Weeks
Time frame: Within 48 weeks of randomization to study medications
Secondary Efficacy Endpoints
Time frame: week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20386077Molto J, Valle M, Santos JR, Mothe B, Miranda C, Cedeno S, Negredo E, Yritia M, Videla S, Barbanoj MJ, Clotet B. Treatment simplification to once daily darunavir/ritonavir guided by the darunavir inhibitory quotient in heavily pretreated HIV-infected patients. Antivir Ther. 2010;15(2):219-25. doi: 10.3851/IMP1519.
- Derived from this study: PubMed 25881614Huhn GD, Sigman A, Livak B. Simplification from twice-daily to once-daily darunavir/ritonavir in a randomized trial among HIV-infected persons with HIV-1 RNA suppression on antiretroviral therapy. Antivir Ther. 2015;20(8):849-54. doi: 10.3851/IMP2962. Epub 2015 Apr 17.
- published resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GREGORY G HUHN, MD principal investigator
The Ruth M. Rothstein CORE Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Twice-daily combination Darunavir and ritonavir and Once-daily combination Darunavir and ritonavir in people with HIV, run by Ruth M. Rothstein CORE Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint for Virologic Suppression in HIV-infected Subjects (time frame: 48 weeks after randomization to study medication). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01423812, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.